PF-08634404 + Chemotherapy for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effectiveness of a new medicine, PF-08634404 (an experimental treatment), for people with Transformed Small Cell Lung Cancer (T-SCLC). The trial will assess the medicine's efficacy both alone and in combination with chemotherapy, which kills or stops cancer cell growth. Individuals with T-SCLC who previously had a specific type of lung cancer treated with targeted pills and have not yet received treatment for T-SCLC may be suitable candidates for this trial. Participants will receive treatments through IV infusions, with a medical team closely monitoring them. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications like high-dose systemic corticosteroids, specific anticoagulants, or live vaccines are prohibited within specific timeframes. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that PF-08634404 is likely to be safe for humans?
Earlier studies have shown that PF-08634404 is safe when used alone or with chemotherapy. Research indicates that patients generally tolerated the treatment well. So far, no major safety issues have emerged. For those considering joining a trial, this suggests that while some side effects might occur, they are usually manageable. Discuss any concerns with the medical team conducting the trial.12345
Why do researchers think this study treatment might be promising for small cell lung cancer?
Unlike the standard chemotherapy treatments for small cell lung cancer, PF-08634404 offers a unique approach by combining with chemotherapy and then continuing as a maintenance therapy. This new drug potentially enhances the effectiveness of chemotherapy by providing ongoing treatment rather than just during initial cycles. Researchers are excited about PF-08634404 because it may target cancer cells more consistently, potentially leading to better long-term outcomes for patients with this aggressive type of lung cancer.
What evidence suggests that PF-08634404 might be an effective treatment for T-SCLC?
Research suggests that PF-08634404, a new treatment tested in this trial, shows promise when combined with chemotherapy for small cell lung cancer (SCLC). Other studies have shown encouraging results in slowing cancer growth and consider it safe when used alone in similar situations. PF-08634404 targets two proteins, PD-1 and VEGF, which help cancer cells evade the immune system and grow new blood vessels. These early findings offer hope that PF-08634404 could effectively treat transformed small cell lung cancer (T-SCLC), but further research is needed to confirm these effects.12367
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults (18+) with transformed small cell lung cancer (T-SCLC) that developed from EGFR-mutated non-small cell lung cancer after TKI treatment. Participants must be in good health, have not received prior treatment for T-SCLC (except possibly one chemo cycle), and meet specific lab and organ function requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Combination Treatment
Participants receive PF-08634404 in combination with chemotherapy through IV infusions
Maintenance Therapy
Participants continue with PF-08634404 alone after combination treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- PF-08634404
Trial Overview
The study tests a new medicine called PF-08634404 given with chemotherapy through IV infusions to see how well it works for T-SCLC. After the initial combination phase, participants continue on PF-08634404 alone. All treatments are monitored at clinical sites.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
NCT07226999 | Symbiotic-Lung-04: A Study to Learn ...
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with ...
440TiP A phase II/III trial of a PD-1/VEGF bispecific ...
This study will evaluate the outcomes of PF-08634404 in combination with chemotherapy in extensive-stage small cell lung cancer (ES-SCLC). Trial design.
PD-1 x VEGF Bispecific Antibody
PD-1 x VEGF Bispecific Antibody. PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
1328 SSGJ-707, a PD-1/VEGF bispecific antibody ...
Results from a phase 2 study demonstrated promising efficacy and manageable safety as monotherapy in first-line NSCLC with tumor proportion ...
5.
medicine.yale.edu
medicine.yale.edu/publication-details/phase-ii-iii-trial-of-pd-1-vegf-antibody-in-small-cell-lung-cancer/Phase II/III Trial of PD-1/VEGF Antibody in Small Cell Lung ...
This study examines the effectiveness and safety of a new treatment approach combining PF-08634404, a bispecific antibody targeting PD-1 (a ...
6.
pfizerclinicaltrials.com
pfizerclinicaltrials.com/find-a-trial/nct07226999-small-cell-lung-cancer-sclc-trialClinical Trial for Small Cell Lung Cancer (SCLC).
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with ...
NCT07476287 | Symbiotic-Lung-14: A Study to Learn ...
The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses ...
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